Methods And Applications Of Statistics In Clinical Trials Volume 1

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Methods and Applications of Statistics in Clinical Trials, Volume 1

N. Balakrishnan
Methods and Applications of Statistics in Clinical Trials Volume 1 Book PDF

Author : N. Balakrishnan
Publisher : John Wiley & Sons
Page : 992 pages
File Size : 50,8 Mb
Release : 2014-03-05
Category : Medical
ISBN : 9781118595916

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Methods and Applications of Statistics in Clinical Trials, Volume 1 by N. Balakrishnan Pdf

A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2

Narayanaswamy Balakrishnan
Methods and Applications of Statistics in Clinical Trials Volume 1 and Volume 2 Book PDF

Author : Narayanaswamy Balakrishnan
Publisher : Wiley
Page : 0 pages
File Size : 48,9 Mb
Release : 2014-05-27
Category : Medical
ISBN : 1118790782

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Methods and Applications of Statistics in Clinical Trials, Volume 1 and Volume 2 by Narayanaswamy Balakrishnan Pdf

This set includes Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs & Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods. Volume 1 Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs successfully upholds the goals of the Wiley Encyclopedia of Clinical Trials by combining both previously-published and newly developed contributions written by over 100 leading academics, researchers, and practitioners in a comprehensive, approachable format. The result is a succinct reference that unveils modern, cutting-edge approaches to acquiring and understanding data throughout the various stages of clinical trial design and analysis. Volume 2 Featuring newly-written material as well as established literature from the Wiley Encyclopedia of Clinical Trials, this book provides a timely and authoritative review of techniques for planning clinical trials as well as the necessary inferential methods for analyzing collected data. This comprehensive volume features established and newly-written literature on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. Examples of ongoing, cutting-edge clinical trials from today's research such as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS clinical trials are also explored.

Methods and Applications of Statistics in Clinical Trials, Volume 1

N. Balakrishnan
Methods and Applications of Statistics in Clinical Trials Volume 1 Book PDF

Author : N. Balakrishnan
Publisher : Unknown
Page : 992 pages
File Size : 53,6 Mb
Release : 2014
Category : Health
ISBN : OCLC:1105772291

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Methods and Applications of Statistics in Clinical Trials, Volume 1 by N. Balakrishnan Pdf

A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials . Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology, and public health.

Methods and Applications of Statistics in Clinical Trials, Volume 2

N. Balakrishnan
Methods and Applications of Statistics in Clinical Trials Volume 2 Book PDF

Author : N. Balakrishnan
Publisher : John Wiley & Sons
Page : 960 pages
File Size : 43,9 Mb
Release : 2014-06-16
Category : Medical
ISBN : 9781118595961

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Methods and Applications of Statistics in Clinical Trials, Volume 2 by N. Balakrishnan Pdf

Methods and Applications of Statistics in Clinical Trials,Volume 2: Planning, Analysis, and Inferential Methods includesupdates of established literature from the Wiley Encyclopedia ofClinical Trials as well as original material based on the latestdevelopments in clinical trials. Prepared by a leading expert, thesecond volume includes numerous contributions from currentprominent experts in the field of medical research. In addition,the volume features: • Multiple new articles exploring emerging topics, such asevaluation methods with threshold, empirical likelihood methods,nonparametric ROC analysis, over- and under-dispersed models, andmulti-armed bandit problems • Up-to-date research on the Cox proportional hazardmodel, frailty models, trial reports, intrarater reliability,conditional power, and the kappa index • Key qualitative issues including cost-effectivenessanalysis, publication bias, and regulatory issues, which arecrucial to the planning and data management of clinical trials

Methods and Applications of Statistics in Clinical Trials, Volume 2

N. Balakrishnan
Methods and Applications of Statistics in Clinical Trials Volume 2 Book PDF

Author : N. Balakrishnan
Publisher : Wiley
Page : 960 pages
File Size : 47,7 Mb
Release : 2014-05-16
Category : Medical
ISBN : 1118595882

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Methods and Applications of Statistics in Clinical Trials, Volume 2 by N. Balakrishnan Pdf

"This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. It discusses the various kinds of trials that can be found in today's clinical setting including open-labeled trials, multicentered trials, and superiority trials. It also explores such ongoing, cutting-edge trials as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS"--Provided by publisher.

Introduction to Statistical Methods for Clinical Trials

Thomas D. Cook,David L DeMets
Introduction to Statistical Methods for Clinical Trials Book PDF

Author : Thomas D. Cook,David L DeMets
Publisher : CRC Press
Page : 465 pages
File Size : 41,8 Mb
Release : 2007-11-19
Category : Mathematics
ISBN : 9781584880271

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Introduction to Statistical Methods for Clinical Trials by Thomas D. Cook,David L DeMets Pdf

Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Statistical Methods in Medical Research

Peter Armitage,Geoffrey Berry,J. N. S. Matthews
Statistical Methods in Medical Research Book PDF

Author : Peter Armitage,Geoffrey Berry,J. N. S. Matthews
Publisher : John Wiley & Sons
Page : 832 pages
File Size : 43,6 Mb
Release : 2013-07-01
Category : Medical
ISBN : 9781118702581

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Statistical Methods in Medical Research by Peter Armitage,Geoffrey Berry,J. N. S. Matthews Pdf

The explanation and implementation of statistical methods for themedical researcher or statistician remains an integral part ofmodern medical research. This book explains the use of experimentaland analytical biostatistics systems. Its accessible style allowsit to be used by the non-mathematician as a fundamental componentof successful research. Since the third edition, there have been many developments instatistical techniques. The fourth edition provides the medicalstatistician with an accessible guide to these techniques and toreflect the extent of their usage in medical research. The new edition takes a much more comprehensive approach to itssubject. There has been a radical reorganization of the text toimprove the continuity and cohesion of the presentation and toextend the scope by covering many new ideas now being introducedinto the analysis of medical research data. The authors have triedto maintain the modest level of mathematical exposition thatcharacterized the earlier editions, essentially confining themathematics to the statement of algebraic formulae rather thanpursuing mathematical proofs. Received the Highly Commended Certificate in the PublicHealth Category of the 2002 BMA BooksCompetition.

Clinical Trial Data Analysis Using R

Ding-Geng (Din) Chen,Karl E. Peace
Clinical Trial Data Analysis Using R Book PDF

Author : Ding-Geng (Din) Chen,Karl E. Peace
Publisher : CRC Press
Page : 384 pages
File Size : 43,9 Mb
Release : 2010-12-14
Category : Mathematics
ISBN : 9781439840214

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Clinical Trial Data Analysis Using R by Ding-Geng (Din) Chen,Karl E. Peace Pdf

Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical Trial Data Analysis Using R provides a thorough presentation of biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. The book’s practical, detailed approach draws on the authors’ 30 years of real-world experience in biostatistical research and clinical development. Each chapter presents examples of clinical trials based on the authors’ actual experiences in clinical drug development. Various biostatistical methods for analyzing the data are then identified. The authors develop analysis code step by step using appropriate R packages and functions. This approach enables readers to gain an understanding of the analysis methods and R implementation so that they can use R to analyze their own clinical trial data. With step-by-step illustrations of R implementations, this book shows how to easily use R to simulate and analyze data from a clinical trial. It describes numerous up-to-date statistical methods and offers sound guidance on the processes involved in clinical trials.

Statistical Monitoring of Clinical Trials

Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes
Statistical Monitoring of Clinical Trials Book PDF

Author : Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes
Publisher : Springer Science & Business Media
Page : 268 pages
File Size : 55,5 Mb
Release : 2006-12-31
Category : Medical
ISBN : 9780387449708

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Statistical Monitoring of Clinical Trials by Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes Pdf

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials.

Statistical Thinking in Clinical Trials

Michael A. Proschan
Statistical Thinking in Clinical Trials Book PDF

Author : Michael A. Proschan
Publisher : CRC Press
Page : 270 pages
File Size : 42,8 Mb
Release : 2021-11-24
Category : Mathematics
ISBN : 9781351673112

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Statistical Thinking in Clinical Trials by Michael A. Proschan Pdf

Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. Other principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ’ principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V’ principle provides a simple estimator of the log odds ratio that is ideally suited for stratified analysis with a binary outcome. The same principle can be used to estimate the log hazard ratio and facilitate stratified analysis in a survival setting. Learn these and other simple techniques that will make you an invaluable clinical trial statistician.

Handbook for Clinical Research

Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD
Handbook for Clinical Research Book PDF

Author : Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD
Publisher : Demos Medical Publishing
Page : 348 pages
File Size : 42,6 Mb
Release : 2014-08-26
Category : Medical
ISBN : 9781936287543

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Handbook for Clinical Research by Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD Pdf

The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended as a “quick fix”, allowing readers to look up information rapidly about various design types and statistical methods to see what the pros, cons, and indications for each are. Research implementation, including regulatory issues and grant writing, is also covered. The book is unique in physical medicine and rehabilitation, and with the increased emphasis on outcomes measurement and push toward a national agenda for disability research, will appeal both to investigators planning and executing studies and clinicians looking to better understand how the findings impact their practice. A list of topics with an outline of headings for each of the sections is attached.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 409 pages
File Size : 42,9 Mb
Release : 2018-08-20
Category : Medical
ISBN : 9789811078293

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Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the first of the 3-volume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.

Design of Experiments and Advanced Statistical Techniques in Clinical Research

Basavarajaiah D. M.,Bhamidipati Narasimha Murthy
Design of Experiments and Advanced Statistical Techniques in Clinical Research Book PDF

Author : Basavarajaiah D. M.,Bhamidipati Narasimha Murthy
Publisher : Springer Nature
Page : 380 pages
File Size : 46,6 Mb
Release : 2020-11-05
Category : Medical
ISBN : 9789811582103

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Design of Experiments and Advanced Statistical Techniques in Clinical Research by Basavarajaiah D. M.,Bhamidipati Narasimha Murthy Pdf

Recent Statistical techniques are one of the basal evidence for clinical research, a pivotal in handling new clinical research and in evaluating and applying prior research. This book explores various choices of statistical tools and mechanisms, analyses of the associations among different clinical attributes. It uses advanced statistical methods to describe real clinical data sets, when the clinical processes being examined are still in the process. This book also discusses distinct methods for building predictive and probability distribution models in clinical situations and ways to assess the stability of these models and other quantitative conclusions drawn by realistic experimental data sets. Design of experiments and recent posthoc tests have been used in comparing treatment effects and precision of the experimentation. This book also facilitates clinicians towards understanding statistics and enabling them to follow and evaluate the real empirical studies (formulation of randomized control trial) that pledge insight evidence base for clinical practices. This book will be a useful resource for clinicians, postgraduates scholars in medicines, clinical research beginners and academicians to nurture high-level statistical tools with extensive scope.

Statistics Applied to Clinical Trials

Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Statistics Applied to Clinical Trials Book PDF

Author : Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas
Publisher : Springer Science & Business Media
Page : 550 pages
File Size : 47,9 Mb
Release : 2008-12-16
Category : Mathematics
ISBN : 9781402095238

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Statistics Applied to Clinical Trials by Ton J. Cleophas,A.H. Zwinderman,Toine F. Cleophas,Eugene P. Cleophas Pdf

In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.

Clinical Trial Data Analysis Using R and SAS

Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang
Clinical Trial Data Analysis Using R and SAS Book PDF

Author : Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang
Publisher : CRC Press
Page : 378 pages
File Size : 40,6 Mb
Release : 2017-06-01
Category : Mathematics
ISBN : 9781498779531

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Clinical Trial Data Analysis Using R and SAS by Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang Pdf

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.